House and Senate Bills Call for Zohydro Ban

Members of Congress have introduced bills to ban Zohydro and prevent future formulations of opioid drugs that lack abuse-deterrent mechanisms from getting on the market.

Sen. Joe Manchin (D-W.Va.) and Reps. Stephen Lynch (D-Mass.) and Hal Rogers (D-Ky.) separately introduced bills Thursday in the Senate and House to reverse FDA approval of the hydrocodone-only painkiller.

Both bills would prohibit FDA from approving similar drugs unless they're formulated to prevent abuse. The FDA has started to look into implementing such a rule internally but has not yet come to a decision. In the meantime, its rulings have sometimes been contradictory.

"I have tried reasoning with the FDA, and I've repeatedly requested the agency change its course on this dangerous drug," Manchin said in a statement. "Their refusal to budge forces me to introduce legislation."

Both bills were filed after FDA Commissioner Margaret Hamburg's testimony before the Senate Health, Education, Labor and Pensions committee on Thursday, during which she defended her agency's approval of Zohydro.

The drug was shown to reduce chronic low back pain better than placebo, according to a company press release. Purdue said it plans to file a New Drug Application with FDA later in 2014.

The announcement sent shares of Zohydro maker Zogenix tumbling more than 20%, on the expectation that the abuse-deterrent formulation would be preferred, according to the Associated Press.

FDA has not yet released final guidance on the issue of abuse-deterrent properties for opioid painkillers. In January 2013, it issued draft guidance defining properties of abuse-resistance, outlining the types of studies needed to test tamper-resistant technology and describing how FDA will evaluate results of those studies -- but the agency has not yet followed up with a final rule.

Since then, FDA has delivered rulings on issues pertaining to abuse-deterrence that appear inconsistent.

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